Regulatory Affairs Manager, U.S. Advertising and Promotions - Olympus Corporation of the Americas

Working Location: PENNSYLVANIA, BETHLEHEM; PENNSYLVANIA, CENTER VALLEY


Workplace Flexibility: Hybrid





For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. ​ ​


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Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.


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Our five Core Values empower us to achieve Our Purpose:





Patient Focus, Integrity, Innovation, Impact and Empathy.





Learn more about Life at Olympus (https://www.olympusamerica.com/careers) .





Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate.










Job Description



Manager, Regulatory Affairs U.S. Advertising & Promotion will manage the personnel and processes that involve the review of internal and external advertising, promotional (and non-promotional), communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns, including serving as regulatory lead for materials required for product launches in the United States for all divisions of Olympus.







Job Duties




+ This role ensures compliance with FDA regulations, company policies, and industry guidelines


+ Manager will work closely with cross-functional teams to support the development and implementation of regulatory promotional strategies and claims matrices


+ Serves as the leader for the team that is the regulatory reviewer on the Medical Legal and Regulatory Review Committee (MLR) for product promotion, labeling, core sales training materials, and other promotional and non-promotional communications, including social media, press releases, and talking points


+ Coordinates all aspects of regulatory submissions related to promotional materials


+ Ensures regulatory compliance while effectively managing business risks through identifying various strategies for addressing business objectives, advising on risk/benefit towards assisting business’ decisions with a clear understanding of the regulatory framework


+ Monitors and interprets FDA regulations and guidelines, including FDA warning and untitled letters, relevant to device promotion and advertising


+ Develops and implements regulatory training programs for cross-functional partners


+ Provides guidance and feedback to internal Business (e.g., Sales, Medical, Market Access) to ensure that promotional and non-promotional practices align with regulatory guidelines and support business objectives


+ Other duties as assigned






Job Qualifications



Required:



+ BA or BS in a Science Related Field (Engineering, Bioengineering)


+ Minimum of 8 years’ experience in Regulatory Affairs in Medical Device Industry.


+ Supervisory experience is required as this position will manage a small team of RA professionals.


+ Travel: Less than 5%






Preferred:



+ Highly collaborative with a strong attention to detail, organized, ability to execute, flexible and adaptable, ethical, strong communication skills (verbal, written, etc.), and ability to work across multiple departments.


+ Extensive knowledge of medical device regulations.


+ Experience with a medical device quality system.


+ Good recordkeeping and attention to detail


+ Organizational skills, detail oriented, trustworthy






Why join Olympus?





We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.





Equitable Offerings you can count on:

+ Competitive salaries, annual bonus and 401(k)* with company match

+ Comprehensive medical, dental, vision coverage effective on start date

+ 24/7 Employee Assistance Program

+ Free live and on-demand Wellbeing Programs

+ Generous Paid Vacation and Sick Time

+ Paid Parental Leave and Adoption Assistance*

+ 12 Paid Holidays

+ On-Site Child Daycare, Café, Fitness Center







Connected Culture you can embrace:

+ Work-life integrated culture that supports an employee centric mindset

+ Offers onsite, hybrid and field work environments

+ Paid volunteering and charitable donation/match programs

+ Diversity Equity & Inclusion Initiatives including Employee Resource Groups

+ Dedicated Training Resources and Learning & Development Programs

+ Paid Educational Assistance







*US Only





**Center Valley, PA and Westborough, MA








Are you ready to be a part of our team?





Learn more about our benefit and incentives (https://www.olympusamerica.com/careers/benefits-perks) .











At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.





For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.





Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com .





Olympus is dedicated to building a diverse, inclusive and authentic workplace





We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.





Let’s realize your potential, together.





It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.





Applicants with Disabilities:





As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone. If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).





Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA)